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CTRI Number  CTRI/2022/11/046988 [Registered on: 02/11/2022] Trial Registered Prospectively
Last Modified On: 23/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of photodynamic therapy as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus: A pilot randomized control trial 
Scientific Title of Study   ROLE OF PHOTODYNAMIC THERAPY AS AN ADJUNCT TO SCALING AND ROOT PLANING IN CHRONIC PERIODONTITIS PATIENTS WITH TYPE 2 DIABETES MELLITUS: A PILOT RANDOMIZED CONTROL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SUMITA MANANDHAR 
Designation  Resident 
Affiliation  Armed Forces Medical college 
Address  Division of periodontology, Department of Dental surgery and OHS, AFMC

Pune
MAHARASHTRA
411040
India 
Phone  8177854878  
Fax    
Email  sumitamanandhar.sm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T Prasanth 
Designation  Prof & HOD 
Affiliation  Armed Forces Medical college 
Address  Division of periodontology, Department of Dental surgery and OHS, AFMC

Pune
MAHARASHTRA
411040
India 
Phone  8284851155  
Fax    
Email  tprasanthavin@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SUMITA MANANDHAR 
Designation  Resident 
Affiliation  Armed Forces Medical college 
Address  Division of periodontology, Department of Dental surgery and OHS, AFMC

Pune
MAHARASHTRA
411040
India 
Phone  8177854878  
Fax    
Email  sumitamanandhar.sm@gmail.com  
 
Source of Monetary or Material Support  
Division of periodontology, Dept of Dental surgery and OHS, AFMC,Pune 
 
Primary Sponsor  
Name  Sumita Manandhar  
Address  Single officer foreign accomodation, AFMC, Pune 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SUMITA MANANDHAR  AFMC, PUNE  Division of Periodontology, Dept of Dental Surgery and OHS, AFMC
Pune
MAHARASHTRA 		 8177854878

sumitamanandhar.sm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  control group  role of Scaling and root planing in chronic generalised periodontitis with type 2 diabetes mellitus within 3 months 
Comparator Agent  Photodynamic therapy using methylene blue dye and diode laser 660nm  role of Scaling and root planing with photodynamic therapy in chronic generalised periodontitis with type 2 diabetes mellitus within 3 months 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Confirmed diagnosis of type 2 diabetes, Glycated haemoglobin (HbA1c) values more than 7% and no more than 10% taken 3 months prior to selection in the study, Patients diagnosed with a case of generalized moderate to severe chronic periodontitis, Patients with at least 20 remaining teeth, Willing to comply with the study-related procedures
 
 
ExclusionCriteria 
Details  Pregnant and lactating women, Smokers,Patients with uncontrolled diabetes mellitus even after medications, Patients who received periodontal treatment or antibiotic therapy last 6 months, Patients allergic to photosensitizer dye, Refusal or inability to give informed consent
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess post treatment changes in Probing depth, Clinical Attachment loss, Bleeding on Probing , Plaque Index , HbA1c levels, TNF-α   Baseline and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess post treatment changes of Bleeding on Probing , Plaque Index HbA1c levels, TNF-α  Baseline and 3 months 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/10/2023 
Date of Study Completion (India) 20/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sumitamanandhar.sm@gmail.com].

  6. For how long will this data be available start date provided 31-08-2022 and end date provided 01-12-2022?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Periodontitis is a chronic inflammatory disease characterized by periodontal destruction and is the sixth complication of diabetes. Patients with periodontal disease and diabetes have hyperinflammatory immune cells that elevate proinflammatory cytokines resulting in periodontal destruction. Photodynamic therapy (PDT) involves the use of photosensitizer dye, a low-level diode laser of a specific wavelength which gets activated and releases free radicals that are specific to target cells. Advantages of PDT are its specificity to cells, no lateral damage, and lack of development of resistant bacterial species. The aim of this study is to describe the role of PDT on periodontal status, immunological parameters and diabetic control of chronic periodontitis patients with type 2 diabetes when used as an adjunct to scaling and root planing. The study is a pilot study with 15 patients on each arm; however,17 patients will be selected for loss to follow-up. Patients fulfilling the inclusion and exclusion criteria will be selected and patients will be randomly divided using block randomization into test and control groups after taking consent. The test group will receive additional photodynamic therapy as an adjunct to scaling and root planing and parameters will be recorded like clinical (probing depth, clinical attachment loss, bleeding on probing, plaque index), Hba1c levels, TNF-@ levels at baseline and after 3 months post-treatment. 
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